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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 054 Date of Entry 07/06/2020 
FR Recognition Number 9-125
CIE ISO 11664-2 S 014-2/E First edition 2007-10-15 Corrected version 2008-11-01 Colorimetry - Part 2: CIE standard illuminants
This International Standard specifies two illuminants for use in colorimetry. The illuminants, which are defined in clauses 4 and 5 of this International Standard, are as follows:

a) CIE standard illuminant A

This is intended to represent typical, domestic, tungsten-filament lighting. Its relative spectral power distribution is that of a Planckian radiator at a temperature of approximately 2 856 K. CIE standard illuminant A should be used in all applications of colorimetry involving the use of incandescent lighting, unless there are specific reasons for using a different illuminant.

b) CIE standard illuminant D65

This is intended to represent average daylight and has a correlated colour temperature of approximately 6 500 K. CIE standard illuminant D65 should be used in all colorimetric calculations requiring representative daylight, unless there are specific reasons for using a different illuminant. Variations in the relative spectral power distribution of daylight are known to occur, particularly in the ultraviolet spectral region, as a function of season, time of day, and geographic location. However, CIE standard illuminant D65 should be used pending the availability of additional information on these variations.

Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§876.1500 Angioscope Class 2 LYK
§876.1500 Anoscope And Accessories Class 2 FER
§876.1500 Choledochoscope And Accessories, Flexible/Rigid Class 2 FBN
§876.1500 Colonoscope And Accessories, Flexible/Rigid Class 2 FDF
§876.1500 Cystoscope And Accessories, Flexible/Rigid Class 2 FAJ
§876.1500 Cystourethroscope Class 2 FBO
§876.1500 Duodenoscope And Accessories, Flexible/Rigid Class 2 FDT
§876.1500 Endoscope, Flexible Class 2 GCQ
§876.1500 Endoscope, Rigid Class 2 GCM
§876.1500 Enteroscope And Accessories Class 2 FDA
§876.1500 Kit, Nephroscope Class 2 FGA
§876.1500 Laparoscope, General & Plastic Surgery Class 2 GCJ
§876.1500 Resectoscope Class 2 FJL
§876.1500 Sigmoidoscope And Accessories, Flexible/Rigid Class 2 FAM
§876.1500 Sigmoidoscope, Rigid, Electrical Class 2 FAN
§876.1500 Telescope, Rigid, Endoscopic Class 2 FBP
§876.1500 Ureteroscope And Accessories, Flexible/Rigid Class 2 FGB
§876.1500 Urethroscope Class 2 FGC
§884.1630 Colposcope (And Colpomicroscope) Class 2 HEX
§884.1630 Vaginoscope And Accessories Class 2 MOK
§884.1640 Culdoscope (And Accessories) Class 2 HEW
§884.1690 Falloposcope Class 2 MKO
§884.1690 Hysteroscope (And Accessories) Class 2 HIH
§884.1720 Laparoscope, Gynecologic (And Accessories) Class 2 HET
§864.1860 Automated Digital Image Manual Interpretation Microscope Class 2 OEO
§864.3700 Digital Pathology Display Class 2 PZZ
§864.3700 Digital Pathology Image Viewing And Management Software Class 2 QKQ
§864.3700 Whole Slide Imaging System Class 2 PSY
Relevant FDA Guidance and/or Supportive Publications*
* Submission Guidance for a 510(k): Hysteroscopes and Gynecologic Laparoscopes, Issued March 7, 1996.
* Guidance for Industry and FDA Staff: Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices, Issued April 2016.
* Cheng, W.C., Saleheen, F., and Badano, A. (2019). Assessing color performance of whole-slide imaging scanners for digital pathology. Color Research & Application, 44(3), 322-334.
* Lemaillet P. & Cheng W.C. (2020). Colorimetrical uncertainty of a hyperspectral imaging microscopy system for assessing whole-slide imaging devices. Biomedical Optics Express, 11(3), 1449-1461.
FDA Technical Contact
 Wei-Chung Cheng
Standards Development Organizations
CIE International Commission on Illumination http://cie.co.at/
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Groups (STG)
ObGyn/Gastroenterology/Urology (primary)
*These are provided as examples and others may be applicable.